Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K103204 |
Device Name |
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY |
Applicant |
SOLARC SYSTEMS INC. |
1515 SNOW VALLEY ROAD |
MINESING,ONTARIO,
CA
L0L 1Y3
|
|
Applicant Contact |
BRUCE ELLIOTT |
Correspondent |
SOLARC SYSTEMS INC. |
1515 SNOW VALLEY ROAD |
MINESING,ONTARIO,
CA
L0L 1Y3
|
|
Correspondent Contact |
BRUCE ELLIOTT |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 11/01/2010 |
Decision Date | 04/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00771732
|
Reviewed by Third Party |
No
|
Combination Product |
No
|